Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials, 72687-72690 [2014-28634]

Download as PDF Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1697] Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials AGENCY: Food and Drug Administration, HHS. Notice of a Privacy Act system of records. ACTION: In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration’s (FDA or the Agency) regulations for the protection of privacy, FDA is publishing notice of a Privacy Act system of records entitled, ‘‘FDA Commissioning of State and Local Officials, HHS/FDA/ORA’’ System No. 09–10–0022. FDA is deleting the System of Records Notice (SORN) for ‘‘FDA Credential Holder File, HHS/FDA/OC’’ System No. 09–10–0003, because the records covered by that SORN are now covered by this new SORN and by existing personnel records SORNs. The new system of records will contain information about State and local officials who have applied for an FDA commission that would allow them to assist FDA with its regulatory compliance and enforcement efforts. FDA will use the records in this system to assess qualifications of commissioning candidates, initiate background investigations, record the status of applications, and track the status of commissioned officials. DATES: Effective Date: The new system of records will be effective on December 8, 2014 with the exception of the routine uses. The routine uses will be effective on January 22, 2015. Submit either electronic or written comments by January 22, 2015. ADDRESSES: You may submit comments by any of the following methods: SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 20:19 Dec 05, 2014 Jkt 235001 Instructions: All submissions received must include the Docket No. FDA– 2014–N–1697 for this notice. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ryan Cates, Office of Partnerships, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20857, 301–796–5390, FAX: 301–827–3588, OP–ORA@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background on the New System and the Deleted System The FDA is establishing a new system of records referred to as the Commissioning of State and Local Officials (COSLO) system, to maintain records regarding State and local officials who apply to be commissioned by FDA. Under section 702(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 372(a)(1)(A)), FDA can commission a health, food, or drug officer or employee of any State, territory, or political subdivision thereof (hereafter State and local officials) to conduct examinations and investigations for the purposes of the FD&C Act. In addition, FDA is deleting the SORN entitled ‘‘FDA Credential Holder File, HHS/FDA/OC’’ (System No. 09–10– 0003). The records covered by that SORN (credential records for FDA employees and commissioned officials) will now be covered by this SORN for the COSLO system which contains records pertaining to commissioned officials, and by other existing personnel SORNs for records pertaining to FDA employees. Issued in Homeland Security Presidential Directive 12, ‘‘Policy for a Common Identification Standard for Federal Employees and Contractors,’’ FDA has completed the process of issuing Personal Identity Verification (PIV) badges to current employees and contractors, and will do the same for all PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 72687 new employees and contractors hired in the future. Records pertaining to those badges and background investigations are covered under HHS departmentwide SORN No. 09–90–0777 entitled ‘‘Facility and Resource Access Control Records System.’’ Any additional records maintained to identify or manage FDA personnel designated to conduct examinations and inspections under the FD&C Act would be covered by HHS department-wide SORN No. 09– 90–0018 entitled ‘‘Personnel Records in Operating Offices’’ or another personnel SORN. State and local officials who assist with FD&C Act examinations and inspections are issued one or two types of credentials that differ in scope. All commissioned individuals receive Certificates of Commission and are permitted to receive and review FDA documents. A subset of commissioned individuals also receive personal ‘‘pocket credentials’’ identifying them as FDA commissioned officers and authorizing them to perform additional activities such as conducting inspections, collecting samples, and verifying records. To obtain pocket credentials, State and local officials undergo an Office of Personnel Management level 5 background investigation. FDA commission credentials are different from the PIV badges issued to FDA employees and contractors, and are manufactured and issued by FDA’s Office of Security Operations, and are not within the scope of HHS department-wide SORN No. 09–90–0777. II. The Privacy Act The Privacy Act of 1974 (Pub. L. 93– 579) (5 U.S.C. 552a), as amended, governs the means by which the U.S. Government collects, maintains, and uses information about individuals in a system of records. A ‘‘system of records’’ is a group of any records under the control of a Federal Agency from which information about an individual is retrieved by the individual’s name or other personal identifier. The Privacy Act requires each Agency to publish in the Federal Register a SORN identifying and describing each system of records the Agency maintains, including the purposes for which the Agency uses information about individuals in the system, the routine uses for which the Agency discloses such information outside the Agency, and how individual record subjects can exercise their rights under the Privacy Act (for example, to determine if the system contains information about them). E:\FR\FM\08DEN1.SGM 08DEN1 72688 Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices A. System Number nature of the authority granted to a commissioned individual, the relevant regulatory program area, the date the commission was issued, and date of expiration. 09–10–0022 B. SYSTEM NAME FDA Commissioning of State and Local Officials, HHS/FDA/ORA. G. AUTHORITY FOR MAINTENANCE OF THE SYSTEM The authorities for maintaining this system are: Section 702(a) of the FD&C Act, 44 U.S.C. 3101, and 5 U.S.C. 301. C. SECURITY CLASSIFICATION Unclassified. D. SYSTEM LOCATION H. PURPOSE(S) OF THE SYSTEM Records are maintained at several FDA Headquarters locations and in component offices of the FDA, in both Montgomery County, MD and field locations across the United States. E. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM The records in this system will contain data collected from the FDA commissioning applications of individuals who are State and local officials who wish to be commissioned under section 702(a)(1)(A) of the FD&C Act. This information is gathered for the purpose of processing and validating each individual’s qualifications for commissioning, to initiate the mandatory background investigation, and to track the status of commissioned officials. Privacy Act notification, access, and amendment rights relative to the records maintained in this system are available only to individuals who are the subject of records in this system. The individuals who are the subjects of the records stored in this system are the State or local officials who are currently commissioned, have applied for a commission, and/or were commissioned or rejected in the past. Although records in the system may contain personally identifiable information related to other individuals, only the specified commissioned or commission-seeking individuals are considered subjects of records in this system. mstockstill on DSK4VPTVN1PROD with NOTICES F. CATEGORIES OF RECORDS IN THE SYSTEM The records in this system will include: Full name, aliases, date of birth, home address, work address, telephone number, work or personal email address, photograph, educational history, job title, agency, division, area of expertise, employment history, supervisor’s name, signature, and the outcome of the background investigation of individuals who apply for a commission. Should a commissioned individual with pocket credentials lose their credentials, he or she will typically file a police report and provide a copy of the report to FDA where it is kept in the individual’s commissioning file. In addition, the records in the system will describe the VerDate Sep<11>2014 20:19 Dec 05, 2014 Jkt 235001 Relevant Agency personnel will use records from this system on a need-toknow basis to: • Centrally gather data enabling FDA to determine the suitability, eligibility, and qualifications of State and local officials to whom FDA might offer commissions; • enable FDA to securely commission and credential State and local officials who are particularly qualified to assist FDA in a special manner for which FDA credentials are required; • ensure the safety and security of FDA facilities, systems, information, and of facility occupants and users; • provide appropriate access to FDA information systems, networks, and resources; • enhance FDA’s ability to ensure the safety of FDA-regulated products through a secure commissioning process; and • centrally gather data on commissioned officials, thereby enabling FDA to efficiently maintain the commissioning program and to support activities, such as quickly ascertaining which officials are particularly qualified to carry out official responsibilities and providing this information as necessary to our State and local counterparts. I. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES These routine uses specify circumstances, in addition to those provided by the Privacy Act at 5 U.S.C. 552a(b), under which records may be disclosed to recipients outside HHS, without the individual record subject’s prior written consent: • Public disclosures may be made (for example, on FDA’s Web site) of the names of commissioned officials, and other basic information, including the identification of their State or local agency, their job titles, the type of commission, any specific commissioned areas, and the date of their commission, to the extent disclosure is not an unwarranted invasion of personal privacy. • Disclosure may be made to appropriate Federal Agencies and Department contractors that have a need PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 to know the information for the purpose of assisting the Department’s efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, provided the information disclosed is relevant and necessary for that assistance. • Disclosure may be made to a Federal, State, local, territorial, tribal, foreign, or other public authority, on request, in connection with the hiring or retention of an employee, the issuance or retention of a security clearance, the letting of a contract, or the issuance or retention of a license, grant, or other benefit, to the extent that the information is relevant and necessary to the requesting Agency’s decision. No disclosure will be made unless the information has been determined to be sufficiently reliable to support a referral to another office within the Agency or to another Federal Agency for criminal, civil, administrative, personnel, or regulatory action. • Disclosure of system information may be made to a State, local, territorial, and tribal agencies or governments to provide copies of records that were originally provided to the Agency by that entity. • Disclosure may be made to Federal Agencies, contractors, and other individuals or entities who perform services for the Agency related to this system of records and who need access to the records to perform those services. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a. • When a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, disclosure may be made to the appropriate public authority, whether Federal, foreign, State, local, or tribal, or otherwise, responsible for enforcing, investigating, or prosecuting such violation, if the information disclosed is relevant to the responsibilities of the Agency or public authority. • Disclosure may be made to a court or other tribunal or adjudicative body in a proceeding, when: Æ The Agency or any component thereof; or Æ any employee of the Agency in his or her official capacity; or Æ any employee of the Agency in his or her individual capacity where the Department of Justice (DOJ) has agreed to represent the employee; or Æ the U.S. Government, is a party to the proceeding or has an interest in such proceeding and, by careful review, the Agency determines that the records are E:\FR\FM\08DEN1.SGM 08DEN1 Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices both relevant and necessary to the proceeding and the use of such records is therefore deemed by the Agency to be for a purpose that is compatible with the purpose for which the Agency collected the records. • Disclosure may be made to the National Archives and Records Administration (NARA) and/or the General Services Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906. • Disclosure may be made to the DOJ when: Æ The Agency or any component thereof; or Æ any employee of the Agency in his or her official capacity; or Æ any employee of the Agency in his or her individual capacity where the Agency or the DOJ has agreed to represent the employee; or Æ the U.S. Government, is a party to litigation or has an interest in such litigation and, by careful review, the Agency determines that the records are both relevant and necessary to the litigation and the use of such records by the DOJ is therefore deemed by the Agency to be for a purpose that is compatible with the purpose for which the Agency collected the records. • In the event HHS/FDA deems it desirable or necessary, in determining whether particular records are required to be disclosed under the Freedom of Information Act, disclosure may be made to the DOJ for the purpose of obtaining its advice. J. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM Records are maintained in hard copy files, image files, electronic hard drive, file servers, and other electronic data storage devices. 2. RETRIEVABILITY To retrieve information, the system database is typically queried using any of the internal data fields. The data fields encompass any data criterion that is entered into the system including, but not limited to, name, FDA region, credential number (if issued pocket credentials), certificate expiration date, State, program area, or authority. mstockstill on DSK4VPTVN1PROD with NOTICES 3. SAFEGUARDS a. Authorized users. Access is restricted to FDA employees and contractors with a Level 5 or higher clearance who have a need for the records in the performance of their duties. b. Procedural and technical safeguards. Technical controls include 20:19 Dec 05, 2014 Jkt 235001 K. RETENTION AND DISPOSAL Commissioning records are maintained in accordance with FDA’s Records Control Schedule and the applicable General Records Schedule and disposition schedules approved by NARA. Commissioning records fall under NARA approved citation N1– 088–09–02 for Commissioning Documents, the Nationwide List of FDA Commissions, and Summary Reports of FDA Commissions. Commissioning documents are deleted/destroyed 5 years after the end of the fiscal year in which a commission is revoked or expires. Records within the nationwide list of FDA commissions are deleted/ destroyed 5 years after the fiscal year when they become obsolete or are superseded. Summary reports of FDA commissions are deleted/destroyed after the nationwide list of FDA Commissions has been updated. L. SYSTEM MANAGER(S) AND ADDRESS 1. STORAGE VerDate Sep<11>2014 identification and authentication of the authorized user, access control, audit and accountability, system and communication protection, timely account disablement/deletion, configuration management, maintenance, system and information integrity, media protection, and incident response. These controls extend to remote users as well. c. Physical safeguards. Physical safeguards include controlled-access buildings where all records (such as diskettes, computer listings, and paper documents) are maintained in secured areas, locked buildings, locked rooms, and locked cabinets. Ryan Cates, Food and Drug Administration, Office of Partnerships, Element Building, 12420 Parklawn Dr., Rockville, MD 20857, 301–796–5390, FAX: 301–827–3588, OP-ORA@ fda.hhs.gov. M. NOTIFICATION PROCEDURE In accordance with 21 CFR part 21 Subpart D, an individual may submit a request to the FDA Privacy Act Coordinator, with a notarized signature, to confirm whether records exist about him or her. Requests should be directed to the FDA Privacy Act Coordinator, Division of Freedom of Information, 12420 Parklawn Dr., ELEM–1029, Rockville, MD 20857. An individual requesting notification via mail should certify in his or her request that he or she is the individual who he or she claims to be and that he or she understands that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 72689 under the Privacy Act subject to a $5,000 fine, and indicate on the envelope and in a prominent manner in the request letter that he or she is making a ‘‘Privacy Act Request.’’ Additional details regarding notification request procedures appear in 21 CFR part 21, subpart D. A commission holder may also request an opportunity to review his or her own file by contacting the appropriate Regional Food and Drug Director. N. RECORD ACCESS PROCEDURES Procedures are the same as above, in the Notification Procedure section. Requesters should also reasonably specify the record contents being sought. Some records may be exempt from access under 5 U.S.C. 552a(d)(5), if they are ‘‘compiled in reasonable anticipation of a civil action or proceeding.’’ If access to requested records is denied, the requester may appeal the denial to the FDA Commissioner. Additional details regarding record access procedures and identity verification requirements appear in 21 CFR part 21, subpart D. O. CONTESTING RECORD PROCEDURES In addition to the procedures described above, requesters should reasonably identify the record, specify the information they are contesting, state the corrective action sought and the reasons for the correction, and provide information justifying why the record is not accurate, complete, timely, or relevant to an FDA purpose. Rules and procedures regarding amendment of Privacy Act records appear in 21 CFR part 21, subpart E. P. RECORD SOURCE CATEGORIES Information in this system is obtained from the following sources: Directly from a commissioned individual or individual under consideration for commissioning; FDA employee; FDA contractor; sponsoring State, local or Federal agency; former sponsoring, employing or commissioning agency; other State, local or Federal agencies; contract employer; and the subject individual’s former employer. Q. RECORDS EXEMPTED FROM CERTAIN PROVISIONS OF THE PRIVACY ACT None. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the E:\FR\FM\08DEN1.SGM 08DEN1 72690 Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: December 1, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28634 Filed 12–5–14; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2031] Request for Nominations on the Food Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Food Advisory Committee for the Center for Food Safety and Applied Nutrition (CFSAN) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Food Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by January 7, 2015 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by January 7, 2015. ADDRESSES: All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Karen Strambler (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:19 Dec 05, 2014 Jkt 235001 mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm. Karen Strambler, Office of Policy, Regulations, and Social Science, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., Rm. 1C–016, College Park, MD 20740, 2400–402– 2589, karen.strambler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting industry representative(s) to the following advisory committee: I. CFSAN Advisory Committee, Food Advisory Committee The Committee reviews and evaluates emerging food safety, nutrition and other food- or cosmetic-related health issues that FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) Broad scientific and technical food- or cosmetic-related issues; (2) the safety of food ingredients and new foods; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with ´ ´ their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: December 1, 2014. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2014–28652 Filed 12–5–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described SUMMARY: E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72687-72690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28634]



[[Page 72687]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1697]


Privacy Act of 1974; Report of a New System of Records; Food and 
Drug Administration Commissioning of State and Local Officials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of a Privacy Act system of records.

-----------------------------------------------------------------------

SUMMARY: In accordance with the requirements of the Privacy Act of 1974 
(the Privacy Act) and the Food and Drug Administration's (FDA or the 
Agency) regulations for the protection of privacy, FDA is publishing 
notice of a Privacy Act system of records entitled, ``FDA Commissioning 
of State and Local Officials, HHS/FDA/ORA'' System No. 09-10-0022. FDA 
is deleting the System of Records Notice (SORN) for ``FDA Credential 
Holder File, HHS/FDA/OC'' System No. 09-10-0003, because the records 
covered by that SORN are now covered by this new SORN and by existing 
personnel records SORNs. The new system of records will contain 
information about State and local officials who have applied for an FDA 
commission that would allow them to assist FDA with its regulatory 
compliance and enforcement efforts. FDA will use the records in this 
system to assess qualifications of commissioning candidates, initiate 
background investigations, record the status of applications, and track 
the status of commissioned officials.

DATES: Effective Date: The new system of records will be effective on 
December 8, 2014 with the exception of the routine uses. The routine 
uses will be effective on January 22, 2015. Submit either electronic or 
written comments by January 22, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1697 for this notice. All comments received may be posted 
without change to https://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ryan Cates, Office of Partnerships, 
Food and Drug Administration, Element Building, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-5390, FAX: 301-827-3588, OP-ORA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background on the New System and the Deleted System

    The FDA is establishing a new system of records referred to as the 
Commissioning of State and Local Officials (COSLO) system, to maintain 
records regarding State and local officials who apply to be 
commissioned by FDA. Under section 702(a)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 372(a)(1)(A)), FDA can 
commission a health, food, or drug officer or employee of any State, 
territory, or political subdivision thereof (hereafter State and local 
officials) to conduct examinations and investigations for the purposes 
of the FD&C Act.
    In addition, FDA is deleting the SORN entitled ``FDA Credential 
Holder File, HHS/FDA/OC'' (System No. 09-10-0003). The records covered 
by that SORN (credential records for FDA employees and commissioned 
officials) will now be covered by this SORN for the COSLO system which 
contains records pertaining to commissioned officials, and by other 
existing personnel SORNs for records pertaining to FDA employees.
    Issued in Homeland Security Presidential Directive 12, ``Policy for 
a Common Identification Standard for Federal Employees and 
Contractors,'' FDA has completed the process of issuing Personal 
Identity Verification (PIV) badges to current employees and 
contractors, and will do the same for all new employees and contractors 
hired in the future. Records pertaining to those badges and background 
investigations are covered under HHS department-wide SORN No. 09-90-
0777 entitled ``Facility and Resource Access Control Records System.'' 
Any additional records maintained to identify or manage FDA personnel 
designated to conduct examinations and inspections under the FD&C Act 
would be covered by HHS department-wide SORN No. 09-90-0018 entitled 
``Personnel Records in Operating Offices'' or another personnel SORN.
    State and local officials who assist with FD&C Act examinations and 
inspections are issued one or two types of credentials that differ in 
scope. All commissioned individuals receive Certificates of Commission 
and are permitted to receive and review FDA documents. A subset of 
commissioned individuals also receive personal ``pocket credentials'' 
identifying them as FDA commissioned officers and authorizing them to 
perform additional activities such as conducting inspections, 
collecting samples, and verifying records. To obtain pocket 
credentials, State and local officials undergo an Office of Personnel 
Management level 5 background investigation. FDA commission credentials 
are different from the PIV badges issued to FDA employees and 
contractors, and are manufactured and issued by FDA's Office of 
Security Operations, and are not within the scope of HHS department-
wide SORN No. 09-90-0777.

II. The Privacy Act

    The Privacy Act of 1974 (Pub. L. 93-579) (5 U.S.C. 552a), as 
amended, governs the means by which the U.S. Government collects, 
maintains, and uses information about individuals in a system of 
records. A ``system of records'' is a group of any records under the 
control of a Federal Agency from which information about an individual 
is retrieved by the individual's name or other personal identifier. The 
Privacy Act requires each Agency to publish in the Federal Register a 
SORN identifying and describing each system of records the Agency 
maintains, including the purposes for which the Agency uses information 
about individuals in the system, the routine uses for which the Agency 
discloses such information outside the Agency, and how individual 
record subjects can exercise their rights under the Privacy Act (for 
example, to determine if the system contains information about them).

[[Page 72688]]

A. System Number

09-10-0022

B. System Name
    FDA Commissioning of State and Local Officials, HHS/FDA/ORA.

C. Security Classification
    Unclassified.

D. System Location
    Records are maintained at several FDA Headquarters locations and in 
component offices of the FDA, in both Montgomery County, MD and field 
locations across the United States.

E. Categories of Individuals Covered by the System
    The records in this system will contain data collected from the FDA 
commissioning applications of individuals who are State and local 
officials who wish to be commissioned under section 702(a)(1)(A) of the 
FD&C Act. This information is gathered for the purpose of processing 
and validating each individual's qualifications for commissioning, to 
initiate the mandatory background investigation, and to track the 
status of commissioned officials.
    Privacy Act notification, access, and amendment rights relative to 
the records maintained in this system are available only to individuals 
who are the subject of records in this system. The individuals who are 
the subjects of the records stored in this system are the State or 
local officials who are currently commissioned, have applied for a 
commission, and/or were commissioned or rejected in the past. Although 
records in the system may contain personally identifiable information 
related to other individuals, only the specified commissioned or 
commission-seeking individuals are considered subjects of records in 
this system.

F. Categories of Records in the System
    The records in this system will include: Full name, aliases, date 
of birth, home address, work address, telephone number, work or 
personal email address, photograph, educational history, job title, 
agency, division, area of expertise, employment history, supervisor's 
name, signature, and the outcome of the background investigation of 
individuals who apply for a commission. Should a commissioned 
individual with pocket credentials lose their credentials, he or she 
will typically file a police report and provide a copy of the report to 
FDA where it is kept in the individual's commissioning file. In 
addition, the records in the system will describe the nature of the 
authority granted to a commissioned individual, the relevant regulatory 
program area, the date the commission was issued, and date of 
expiration.

G. Authority for Maintenance of the System
    The authorities for maintaining this system are: Section 702(a) of 
the FD&C Act, 44 U.S.C. 3101, and 5 U.S.C. 301.

H. Purpose(s) of the System
    Relevant Agency personnel will use records from this system on a 
need-to-know basis to:
     Centrally gather data enabling FDA to determine the 
suitability, eligibility, and qualifications of State and local 
officials to whom FDA might offer commissions;
     enable FDA to securely commission and credential State and 
local officials who are particularly qualified to assist FDA in a 
special manner for which FDA credentials are required;
     ensure the safety and security of FDA facilities, systems, 
information, and of facility occupants and users;
     provide appropriate access to FDA information systems, 
networks, and resources;
     enhance FDA's ability to ensure the safety of FDA-
regulated products through a secure commissioning process; and
     centrally gather data on commissioned officials, thereby 
enabling FDA to efficiently maintain the commissioning program and to 
support activities, such as quickly ascertaining which officials are 
particularly qualified to carry out official responsibilities and 
providing this information as necessary to our State and local 
counterparts.

I. Routine Uses of Records Maintained in the System, Including 
Categories of Users and the Purposes of Such Uses
    These routine uses specify circumstances, in addition to those 
provided by the Privacy Act at 5 U.S.C. 552a(b), under which records 
may be disclosed to recipients outside HHS, without the individual 
record subject's prior written consent:
     Public disclosures may be made (for example, on FDA's Web 
site) of the names of commissioned officials, and other basic 
information, including the identification of their State or local 
agency, their job titles, the type of commission, any specific 
commissioned areas, and the date of their commission, to the extent 
disclosure is not an unwarranted invasion of personal privacy.
     Disclosure may be made to appropriate Federal Agencies and 
Department contractors that have a need to know the information for the 
purpose of assisting the Department's efforts to respond to a suspected 
or confirmed breach of the security or confidentiality of information 
maintained in this system of records, provided the information 
disclosed is relevant and necessary for that assistance.
     Disclosure may be made to a Federal, State, local, 
territorial, tribal, foreign, or other public authority, on request, in 
connection with the hiring or retention of an employee, the issuance or 
retention of a security clearance, the letting of a contract, or the 
issuance or retention of a license, grant, or other benefit, to the 
extent that the information is relevant and necessary to the requesting 
Agency's decision. No disclosure will be made unless the information 
has been determined to be sufficiently reliable to support a referral 
to another office within the Agency or to another Federal Agency for 
criminal, civil, administrative, personnel, or regulatory action.
     Disclosure of system information may be made to a State, 
local, territorial, and tribal agencies or governments to provide 
copies of records that were originally provided to the Agency by that 
entity.
     Disclosure may be made to Federal Agencies, contractors, 
and other individuals or entities who perform services for the Agency 
related to this system of records and who need access to the records to 
perform those services. Recipients shall be required to comply with the 
requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
     When a record on its face, or in conjunction with other 
records, indicates a violation or potential violation of law, whether 
civil, criminal, or regulatory in nature, disclosure may be made to the 
appropriate public authority, whether Federal, foreign, State, local, 
or tribal, or otherwise, responsible for enforcing, investigating, or 
prosecuting such violation, if the information disclosed is relevant to 
the responsibilities of the Agency or public authority.
     Disclosure may be made to a court or other tribunal or 
adjudicative body in a proceeding, when:
    [cir] The Agency or any component thereof; or
    [cir] any employee of the Agency in his or her official capacity; 
or
    [cir] any employee of the Agency in his or her individual capacity 
where the Department of Justice (DOJ) has agreed to represent the 
employee; or
    [cir] the U.S. Government, is a party to the proceeding or has an 
interest in such proceeding and, by careful review, the Agency 
determines that the records are

[[Page 72689]]

both relevant and necessary to the proceeding and the use of such 
records is therefore deemed by the Agency to be for a purpose that is 
compatible with the purpose for which the Agency collected the records.
     Disclosure may be made to the National Archives and 
Records Administration (NARA) and/or the General Services 
Administration for the purpose of records management inspections 
conducted under authority of 44 U.S.C. 2904 and 2906.
     Disclosure may be made to the DOJ when:
    [cir] The Agency or any component thereof; or
    [cir] any employee of the Agency in his or her official capacity; 
or
    [cir] any employee of the Agency in his or her individual capacity 
where the Agency or the DOJ has agreed to represent the employee; or
    [cir] the U.S. Government, is a party to litigation or has an 
interest in such litigation and, by careful review, the Agency 
determines that the records are both relevant and necessary to the 
litigation and the use of such records by the DOJ is therefore deemed 
by the Agency to be for a purpose that is compatible with the purpose 
for which the Agency collected the records.
     In the event HHS/FDA deems it desirable or necessary, in 
determining whether particular records are required to be disclosed 
under the Freedom of Information Act, disclosure may be made to the DOJ 
for the purpose of obtaining its advice.

J. Policies and Practices for Storing, Retrieving, Accessing, 
Retaining, and Disposing of Records in the System
1. Storage
    Records are maintained in hard copy files, image files, electronic 
hard drive, file servers, and other electronic data storage devices.

2. Retrievability
    To retrieve information, the system database is typically queried 
using any of the internal data fields. The data fields encompass any 
data criterion that is entered into the system including, but not 
limited to, name, FDA region, credential number (if issued pocket 
credentials), certificate expiration date, State, program area, or 
authority.

3. Safeguards
    a. Authorized users. Access is restricted to FDA employees and 
contractors with a Level 5 or higher clearance who have a need for the 
records in the performance of their duties.
    b. Procedural and technical safeguards. Technical controls include 
identification and authentication of the authorized user, access 
control, audit and accountability, system and communication protection, 
timely account disablement/deletion, configuration management, 
maintenance, system and information integrity, media protection, and 
incident response. These controls extend to remote users as well.
    c. Physical safeguards. Physical safeguards include controlled-
access buildings where all records (such as diskettes, computer 
listings, and paper documents) are maintained in secured areas, locked 
buildings, locked rooms, and locked cabinets.

K. Retention and Disposal
    Commissioning records are maintained in accordance with FDA's 
Records Control Schedule and the applicable General Records Schedule 
and disposition schedules approved by NARA. Commissioning records fall 
under NARA approved citation N1-088-09-02 for Commissioning Documents, 
the Nationwide List of FDA Commissions, and Summary Reports of FDA 
Commissions. Commissioning documents are deleted/destroyed 5 years 
after the end of the fiscal year in which a commission is revoked or 
expires. Records within the nationwide list of FDA commissions are 
deleted/destroyed 5 years after the fiscal year when they become 
obsolete or are superseded. Summary reports of FDA commissions are 
deleted/destroyed after the nationwide list of FDA Commissions has been 
updated.

L. System Manager(s) and Address
    Ryan Cates, Food and Drug Administration, Office of Partnerships, 
Element Building, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-
5390, FAX: 301-827-3588, OP-ORA@fda.hhs.gov.

M. Notification Procedure
    In accordance with 21 CFR part 21 Subpart D, an individual may 
submit a request to the FDA Privacy Act Coordinator, with a notarized 
signature, to confirm whether records exist about him or her. Requests 
should be directed to the FDA Privacy Act Coordinator, Division of 
Freedom of Information, 12420 Parklawn Dr., ELEM-1029, Rockville, MD 
20857. An individual requesting notification via mail should certify in 
his or her request that he or she is the individual who he or she 
claims to be and that he or she understands that the knowing and 
willful request for or acquisition of a record pertaining to an 
individual under false pretenses is a criminal offense under the 
Privacy Act subject to a $5,000 fine, and indicate on the envelope and 
in a prominent manner in the request letter that he or she is making a 
``Privacy Act Request.'' Additional details regarding notification 
request procedures appear in 21 CFR part 21, subpart D. A commission 
holder may also request an opportunity to review his or her own file by 
contacting the appropriate Regional Food and Drug Director.

N. Record Access Procedures
    Procedures are the same as above, in the Notification Procedure 
section. Requesters should also reasonably specify the record contents 
being sought. Some records may be exempt from access under 5 U.S.C. 
552a(d)(5), if they are ``compiled in reasonable anticipation of a 
civil action or proceeding.'' If access to requested records is denied, 
the requester may appeal the denial to the FDA Commissioner. Additional 
details regarding record access procedures and identity verification 
requirements appear in 21 CFR part 21, subpart D.

O. Contesting Record Procedures
    In addition to the procedures described above, requesters should 
reasonably identify the record, specify the information they are 
contesting, state the corrective action sought and the reasons for the 
correction, and provide information justifying why the record is not 
accurate, complete, timely, or relevant to an FDA purpose. Rules and 
procedures regarding amendment of Privacy Act records appear in 21 CFR 
part 21, subpart E.

P. Record Source Categories
    Information in this system is obtained from the following sources: 
Directly from a commissioned individual or individual under 
consideration for commissioning; FDA employee; FDA contractor; 
sponsoring State, local or Federal agency; former sponsoring, employing 
or commissioning agency; other State, local or Federal agencies; 
contract employer; and the subject individual's former employer.

Q. Records Exempted from Certain Provisions of the Privacy Act
    None.
III. Comments
    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the

[[Page 72690]]

heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at https://www.regulations.gov.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28634 Filed 12-5-14; 8:45 am]
BILLING CODE 4164-01-P
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